Status:
COMPLETED
Magnesium Supplementation to Prevent Bone Loss
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Osteoporosis
Eligibility:
All Genders
55-75 years
Phase:
PHASE1
Brief Summary
Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or action of calcium regulating hormones. Many older adults are at risk for less severe magnesium deficiency, si...
Detailed Description
This is a 12 month randomized, double-blind, placebo-controlled study of magnesium supplementation. Our hypothesis was that magnesium supplementation would decrease bone turnover markers and alter cal...
Eligibility Criteria
Inclusion
- Healthy ambulatory men and women between the ages of 55-75 years
- Women at least 5 years after menopause
Exclusion
- Inability to give informed consent in accordance with institutional guidelines
- Creatinine greater than or equal to 2 mg/dl, since magnesium is excreted by the kidneys
- Diarrhea or loose frequent stools (\> 2 a day) at least 3 days/ week in last 3 months
- Use within 12 months of estrogen, bisphosphonates, calcitonin, or raloxifene
- Current use of loop diuretics
- Use within 12 months of corticosteroids
- History of hyperparathyroidism, hyperthyroidism, or osteomalacia within past 12 month
- Vitamin D deficient as measured by 25-hydroxyvitamin D outside of the normal range
- Magnesium supplementation of greater than 250 mg/day
- Calcium supplementation of greater than 1500 mg/day
- Conditions which, in the opinion of the investigator, would interfere with the evaluation of BMD at the spine including severe scoliosis, osteophytosis and lumbar fusion
- Bilateral hip replacement
- BMD at the lumbar spine L2-L4 of less than 0.859g/cm2 for women or 0.895 g/cm2 in men; or total hip less than 0.698 g/cm2 for women or 0.731 g/cm2 for men; or femoral neck less than 0.627 g/cm2 for women or 0.658 g/cm2 for men This represents a T-score of less than -2 at each site
- High serum calcium on screening blood test
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00346658
Start Date
July 1 2002
End Date
September 1 2006
Last Update
December 15 2008
Active Locations (1)
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1
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163